A Study to Compare the Pharmacokinetics of CSL312 Administered by Prefilled Syringe Assembled to Autoinjector to the Pharmacokinetics Administered by Prefilled Syringe Assembled to Needle Safety Device in Healthy Subjects
NCT ID: NCT05306275
Last Updated: 2022-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
132 participants
INTERVENTIONAL
2022-04-04
2022-09-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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CSL312 AI Abdomen
CSL312 administered subcutaneously (SC) in the abdomen via a prefilled syringe assembled to an autoinjector (AI)
CSL312
Factor XIIa antagonist monoclonal antibody for subcutaneous use
CSL312 AI Thigh
CSL312 administered SC in the thigh via a prefilled syringe assembled to an AI
CSL312
Factor XIIa antagonist monoclonal antibody for subcutaneous use
CSL312 AI Arm
CSL312 administered SC in the upper arm via a prefilled syringe assembled to an AI
CSL312
Factor XIIa antagonist monoclonal antibody for subcutaneous use
CSL312 NSD Abdomen
CSL312 administered SC in the abdomen via a prefilled syringe assembled to a needle safety device (NSD)
CSL312
Factor XIIa antagonist monoclonal antibody for subcutaneous use
CSL312 NSD Thigh
CSL312 administered SC in the thigh via a prefilled syringe assembled to a NSD
CSL312
Factor XIIa antagonist monoclonal antibody for subcutaneous use
CSL312 NSD Arm
CSL312 administered SC in the upper arm via a prefilled syringe assembled to a NSD
CSL312
Factor XIIa antagonist monoclonal antibody for subcutaneous use
Interventions
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CSL312
Factor XIIa antagonist monoclonal antibody for subcutaneous use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body weight in the range of ≥ 50 kg and ≤ 100 kg, with a body mass index (BMI) of ≥ 18 kg/m2 and ≤ 30 kg/m2
Exclusion Criteria
* Evidence of current active infection, including severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2).
* Blood pressure or pulse rate measurements outside the normal range for the subject's age
18 Years
55 Years
ALL
Yes
Sponsors
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CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
CSL Behring
Locations
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Anaheim Clinical Trials, LLC
Anaheim, California, United States
Countries
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Other Identifiers
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CSL312_1004
Identifier Type: -
Identifier Source: org_study_id
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